(14 days)
The TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.
Technical specifications for the Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are as follows:
| Specifications | Tetrad TC-
C52-ATP | Tetrad TC-
C84V-ATP | Tetrad TC-
C95-ATP | Tetrad TC-
CLA76-ATP | Tetrad TC-
L74-ATP |
|---------------------|-----------------------|------------------------|-----------------------|-------------------------|-----------------------|
| Center Frequency | 3.0 MHz
nominal | 6.0 MHz
nominal | 6.0 MHz
nominal | 4.0 MHz
nominal | 6.0 MHz
nominal |
| Number of Elements | 128 | 128 | 128 | 128 | 128 |
| Radius of Curvature | 40 mm | 12 mm | 8 mm | 76 mm | NA |
| Bandwidth -6dB | 70% nominal | 60% nominal | 60% nominal | 50% nominal | >50% |
| Elevation width | 15 mm | 5.5 mm | 4 mm | 15 mm | 5.5 mm |
| Elevation Focus | 80 mm | 25 mm | 25 mm | 75 mm | 25 mm |
| Lens material | silicone | Silicone | silicone | silicone | silicone |
| Pitch | 0.3 mm | 0.2 mm | 0.15 mm | 0.6 mm | 0.2 mm |
The provided 510(k) summary (K0191182) describes the submission for “TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers.” This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific performance criteria through a detailed clinical study.
Therefore, many of the requested information points, such as specific acceptance criteria for diagnostic performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or available in this type of submission.
The primary "study" that proves the device meets acceptance criteria in a 510(k) for a diagnostic ultrasound transducer is a comparison to a legally marketed predicate device and a demonstration that the new device is "substantially equivalent" in terms of technological characteristics and intended use.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this submission are based on demonstrating substantial equivalence to the predicate devices (ATL HDI 3000 and HDI 5000 Systems transducers C5-2, C8-4V, C9-5, C3.5, R76, L7-4). The "performance" is a comparison of technical specifications and the conclusion that the new transducers are functionally similar and have the same intended uses.
| Performance Metric / Criteria Category | Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (TETRAD Transducers) |
|---|---|---|
| Functional Similarity | The device must be functionally similar to the predicate devices. This implies that their operating principles, mechanisms of action, and intended effects on the patient or user are comparable. | The TETRAD transducers are stated to be "functionally similar" to the corresponding ATL products. |
| Intended Use | The device must have the same intended uses as the predicate devices. The listed clinical applications and modes of operation must align. | The TETRAD transducers have the "same intended uses" as the corresponding predicate transducers. Specific indications for use (clinical application, modes of operation) are tabulated in Section 4.3 of the submission (refer to pages 5-9 of the provided document for detailed tables for each transducer model), demonstrating alignment with the predicate ATL transducers. Many applications are marked "N1" which signifies "new indication: predicate (ATL C5-2) cleared for this use with ATL HDI 3000 and ATL HDI 5000", confirming the intended use matches that cleared for the predicate. |
| Technical Specifications | While not explicitly "acceptance criteria" in the sense of a numerical pass/fail, the technical specifications of the new device are compared to the predicate to demonstrate that any differences do not raise new questions of safety or effectiveness. The general expectation is that key specifications associated with image quality and safety are comparable. | TETRAD Model TC-C52-ATP: Center Frequency: 3.0 MHz nominal; Elements: 128; Radius of Curvature: 40 mm; Bandwidth -6dB: 70% nominal; Elevation width: 15 mm; Elevation Focus: 80 mm; Lens material: silicone; Pitch: 0.3 mm. |
TETRAD Model TC-C84V-ATP: Center Frequency: 6.0 MHz nominal; Elements: 128; Radius of Curvature: 12 mm; Bandwidth -6dB: 60% nominal; Elevation width: 5.5 mm; Elevation Focus: 25 mm; Lens material: Silicone; Pitch: 0.2 mm.
TETRAD Model TC-C95-ATP: Center Frequency: 6.0 MHz nominal; Elements: 128; Radius of Curvature: 8 mm; Bandwidth -6dB: 60% nominal; Elevation width: 4 mm; Elevation Focus: 25 mm; Lens material: silicone; Pitch: 0.15 mm.
TETRAD Model TC-CLA76-ATP: Center Frequency: 4.0 MHz nominal; Elements: 128; Radius of Curvature: 76 mm; Bandwidth -6dB: 50% nominal; Elevation width: 15 mm; Elevation Focus: 75 mm; Lens material: silicone; Pitch: 0.6 mm.
TETRAD Model TC-L74-ATP: Center Frequency: 6.0 MHz nominal; Elements: 128; Radius of Curvature: NA; Bandwidth -6dB: >50%; Elevation width: 5.5 mm; Elevation Focus: 25 mm; Lens material: silicone; Pitch: 0.2 mm.
The document explicitly states: "The acoustic output levels of the TETRAD Transducers are equal to or slightly lower than those of their respective corresponding ATL Transducers." This is a key safety comparison. |
| Acoustic Output Levels | Acoustic output levels should be comparable to or lower than the predicate devices to ensure safety. | Stated to be "equal to or slightly lower than those of their respective corresponding ATL Transducers." A post-clearance special report is required to provide complete acoustic output measurements based on production line devices (Appendix G, Sept 30, 1997 guidance). This indicates a commitment to meet the safety thresholds outlined in that guidance. |
| Differences from Predicate | Any differences from the predicate device must not raise new questions of safety or effectiveness. The only substantive differences found during prior clearance (K002193 for TC-C3-ATP) were deemed acceptable. | The only substantive differences identified were related to the acoustic output levels, which were determined to be equal to or slightly lower than the predicate, thus not raising new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable. This 510(k) submission does not describe a clinical trial with a "test set" of patients or images for diagnostic performance evaluation in the way an AI/CADe device would. The evaluation is based on comparing technical specifications and intended use to predicate devices already on the market.
- Data Provenance: Not applicable for a typical "test set" as defined for diagnostic performance. The data provenance for the comparison essentially refers to the existing regulatory clearances and technical specifications of the predicate ATL devices (ATL HDI 3000 and HDI 5000 Systems).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No dedicated "ground truth" establishment by experts for a test set is described in this type of submission for ultrasound transducers.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done. This type of study is not relevant for demonstrating substantial equivalence of an ultrasound transducer in a 510(k) submission focused on technical specifications and intended use comparison. MRMC studies are typically used for assessing the impact of AI/CADe devices on human reader performance.
- Effect Size of Human Readers Improve: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: No, a standalone study was not done. This device is an ultrasound transducer, a hardware component, not an algorithm. Its performance is inherent to its physical and electronic characteristics when connected to an ultrasound system.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No "ground truth" derived from expert consensus, pathology, or outcomes data is used in this submission to evaluate the transducer's diagnostic performance in the context of clinical accuracy. The "ground truth" for substantial equivalence is the existing regulatory clearance and established safety/effectiveness profile of the predicate devices based on their technical specifications and intended uses.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.